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This study evaluates the addition of oral dydrogesterone to standard treatment in the treatment of preterm labor. Half of participants will receive oral dydrogesterone and standard treatment, while the other half will receive oral placebo and standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dydrogesterone | Active Comparator | dydrogesterone 10 mg by mouth every 8 hours until delivery |
|
| Placebo | Placebo Comparator | placebo by mouth every 8 hours until delivery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone | Drug | dydrogesterone capsule |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| latency period | time from preterm labor to delivery | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| preterm delivery less than 34 weeks | percentage of delivery less than 34 weeks | 10 weeks |
| preterm delivery less than 37 weeks | percentage of delivery less than 37 weeks |
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Inclusion Criteria:
Exclusion Criteria:
female
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| Name | Affiliation | Role |
|---|---|---|
| Vorapong Phupong, M.D. | Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Chulalongkorn University | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27661654 | Background | American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711. | |
| 24625129 | Background | Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15. |
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| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
placebo capsule |
|
| 13 weeks |
| neonatal complications | percentage of newborn with RDS, IVH, NEC, death | 13 weeks |
| side effects | percentage of side effects such as headache, nausea/vomiting | 13 weeks |
| compliance | percentage of complete drug use | 13 weeks |
| satisfaction | percentage of good satisfaction | 13 weeks |
| Time to the recurrence of uterine contractions | Time to the recurrence of uterine contractions | 13 weeks |
| 22102929 | Background | Norwitz ER, Caughey AB. Progesterone supplementation and the prevention of preterm birth. Rev Obstet Gynecol. 2011 Summer;4(2):60-72. |
| 29981319 | Background | Yasuda K, Sumi GI, Murata H, Kida N, Kido T, Okada H. The steroid hormone dydrogesterone inhibits myometrial contraction independently of the progesterone/progesterone receptor pathway. Life Sci. 2018 Aug 15;207:508-515. doi: 10.1016/j.lfs.2018.07.004. Epub 2018 Jul 4. |
| 19434889 | Background | Schindler AE, Campagnoli C, Druckmann R, Huber J, Pasqualini JR, Schweppe KW, Thijssen JH. Classification and pharmacology of progestins. Maturitas. 2008 Sep-Oct;61(1-2):171-80. doi: 10.1016/j.maturitas.2008.11.013. |
| 18275573 | Result | Borna S, Sahabi N. Progesterone for maintenance tocolytic therapy after threatened preterm labour: a randomised controlled trial. Aust N Z J Obstet Gynaecol. 2008 Feb;48(1):58-63. doi: 10.1111/j.1479-828X.2007.00803.x. |
| 22086108 | Result | Arikan I, Barut A, Harma M, Harma IM. Effect of progesterone as a tocolytic and in maintenance therapy during preterm labor. Gynecol Obstet Invest. 2011;72(4):269-73. doi: 10.1159/000328719. Epub 2011 Nov 12. |
| 24807871 | Result | Choudhary M, Suneja A, Vaid NB, Guleria K, Faridi MM. Maintenance tocolysis with oral micronized progesterone for prevention of preterm birth after arrested preterm labor. Int J Gynaecol Obstet. 2014 Jul;126(1):60-3. doi: 10.1016/j.ijgo.2014.01.019. Epub 2014 Apr 3. |
| 26856618 | Result | Areeruk W, Phupong V. A randomized, double blinded, placebo controlled trial of oral dydrogesterone supplementation in the management of preterm labor. Sci Rep. 2016 Feb 9;6:20638. doi: 10.1038/srep20638. |
| 33509129 | Derived | Thongchan S, Phupong V. Oral dydrogesterone as an adjunctive therapy in the management of preterm labor: a randomized, double blinded, placebo-controlled trial. BMC Pregnancy Childbirth. 2021 Jan 28;21(1):90. doi: 10.1186/s12884-021-03562-6. |
| D011083 |
| Polycyclic Compounds |